Drug Safety Specialist, Aggregate Reporting

Bioclinica India Private Limited (Mysore, KA, India) 18 hours ago

Essential Duties and Responsibilities:

  • To author/draft aggregate reports like PBRER, PSUR, PADER, DSUR
  • Hands on experience in authoring/drafting Risk management plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)
  • To perform quality review of aggregate reports, RMPs & REMS
  • To draft/author safety assessment reports (SARs)
  • To update RMP/REMS
  • Hands on experience in handling regulatory queries with respect to aggregate reports, RMPs & REMS.
  • Thorough knowledge on interpreting the various line listing documents
  • Knows the metrics of pharmacovigilance with respect to aggregate reports
  • Independently draft the entire safety documents
  • Preparation of PSMF (Pharmacovigilance System Master File)
  • Hands on experience in preparing and managing aggregate report calendars and follow-up with relevant stake holders for documents and coordination as per the reporting timelines.
  • Experience with in depth knowledge of pharmacovigilance and understanding on various health authority requirements with respect to aggregate reports.
  • Well versed and updated on regulatory guidelines.
  • Preparation of Pharmacovigilance/aggregate report Standard Operating Procedures (SOPs) and Work Instructions.
  • Hands on experience in managing aggregate report projects independently taking client benefit and regulatory requirement into consideration.
  • Experience in clear and crisp interactions with clients.

    Specialized knowledge and skills:

  • Basic competence with medical and therapeutic terminology.
  • Proven ability to analyze and interpret aggregate patient safety data relating to drug products
  • Ability to work independently but guided by documented procedures, with appropriate support.
  • Proven ability to interpret and follow the patient safety guidelines of the FDA and comparable international regulatory organizations such as the International Conference on Harmonization
  • Proven experience and report writing skills in accordance with agency requirements for content, format and timelines.
  • Able to work effectively as part of a team.
  • Understanding of patient safety regulatory obligations.
  • Should be familiar regulatory &Pharmacovigilance guidelines.
  • Should be familiar with Pharmacovigilance terminology.
  • Excellent attention to detail.
  • Ability to deliver within established timelines.
  • Fluency in English and excellent comprehension.
  • Computer literate.
  • Relevant product and industry knowledge.
  • Experience with relevant software applications.

    Communication skills:

    Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross‑ departmental communication. Ability to document and communicate problem/resolution and information/ action plans.

    Desired Technical skills:

    Person should be familiar with MS Office Tools.

    Extensive knowledge of US, ICH, and EU PV and GCP regulations

    Excellent strategic decision-making and analytical skills

    Safety database knowledge

    Other skills:

    The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.

    Compliance:

    Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.

    Working Conditions: Normal office environment.

    Hours:

    Standard Hours 40 hours per week, one-hour lunch, Monday – Friday. Additional hours as needed.

    Willing to work in shifts as and when needed

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